A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Intranasal Midazolam (USL261) in the Outpatient Treatment of Subjects With Seizure Clusters. ARTEMIS-1: Acute Rescue Therapy in Epilepsy With Midazolam Intranasal Spray-1

Proportion of subjects who meet the criteria for Treatment Success. [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Treatment Success is defined as achieving both of the following: 1) termination of seizure(s) within 10 minutes after study drug administration, and 2) no recurrence of seizure(s) beginning 10 minutes after study drug administration to 6 hours after study drug administration.

Currently on a stable regimen of AEDs (no changes in type of AEDs) since Visit 1 and for ≥ 7 days before Visit 2, with or without intermittent use of benzodiazepines at a constant dose

Weight is 40kg to 125kg, inclusive

Exclusion Criteria:

Has a neurological disorder that is likely to progress in the next year

Has severe chronic cardio-respiratory disease

Has had psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1

Has a history of their stereotypical seizure cluster progressing to status epilepticus within the 2 years before Visit 1

Has a history of acute narrow-angle glaucoma.

Has had active suicidal plan/intent or active suicidal thoughts in the 6 months before Visit 1 or a suicide attempt in the past 5 years

Currently using a VNS unless the device has been implanted for at least 6 months and the setting stable for 4 weeks before Visit 1

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01390220